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Regulation for E - Pharmacy in India
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Regulation for E - Pharmacy in India

In India, online purchasing of medicines is the latest trend in the market. Due to the increase in buying medicines online, several services of online pharmacies have also increased on a large scale. But, it is observed that there is a lack of proper regulatory provisions to control E-pharmacies. With the help of the advancement of technology, access to medicines through the internet is very easy.

In India, the laws governing pharmacies are derived from the following acts:
Drugs and Cosmetics Act, 1940; 
Drugs and Cosmetics Rules, 1945; 
Pharmacy Act, 1948;
Indian Medical Act, 1956 and Code of Ethics Regulations, 2002 etc.

Primarily, the concept of E-pharmacies comes under the purview of the Drugs and Cosmetics Act, 1940 and the Information Technology Act, 2000.

It is to be noted that the Drugs and Cosmetics Act, 1940 doesn’t distinguish between online and offline pharmacies. Hence, there is a lack of proper and precise laws for e-pharmacies. Regulatory authorities find it challenging to monitor, control, and trace the sale of drugs via the internet as there is a lack of clear guidelines regarding the same. E-pharmacy may be proved as a dangerous trend in future if not regulated appropriately.

E-Pharmacies

The application of the internet to access drugs and diagnostics, which has matured into virtual drugs stores is popularly known as “internet pharmacy”. The arrival of internet pharmacy and access to drugs and diagnostics is gaining popularity due to cost-effectiveness and high-speed delivery to the doorstep of patients. It is also known as Online Pharmacy, Web Pharmacy or Cyber Pharmacy.

E-Prescribing

It is a technology framework that enables the medical practitioners and physicians to send prescriptions to a pharmacy in an electronic way instead of using handwritten notes or calling in prescriptions.

E-Commerce

  • The process of buying and selling goods and services, or the transfer of funds or data, on an electronic network, primarily the internet. The Information Technology Act, 2000, governs all activities and issues connected to the internet. When e-pharmacies regulation is concerned, there is a lack of accurate and unambiguous stated laws and definite guidelines to regulate, monitor and control e-pharmacies. For ensuring the efficient and legitimate running of e-pharmacies, it is a need of the hour to make hassle-free rules for E-pharmacies.

Government’s progress towards the issue of regulation on E- Pharmacies

The Drugs Controller General of India (DCGI) emphasized to keep an eye on the online sale of medicines to stop breaching rules and regulations. Hence all E - pharmacies operating in India are under the regulatory scanner.

Drugs Consultative Committee had constituted a seven-member subcommittee to study the issue of sale of drugs on the internet and associated risks and concerns. Sub-committee review recommended to formulate guidelines on the use of information technology in e-pharmacy and authorize its legal validity.

Federation of Indian Chambers of Commerce and Industry has been appointed as a nodal agency by the Drugs Controller General of India to consolidate and frame guidelines for online sales of medicines through e-commerce channels on June 2015.

Indian Medical Association (IMA) wrote a white paper which shows that IMA strongly opposes e-pharmacies. But objection of white paper could be improved if concerned authorities study it in detail, and proper steps will be taken. Traditional pharmacies owners opposed the online model. So, relevant authorities should think about existing models interest and benefit while drafting new rules for the online model. It should not hurt the business of the existing model players. The new model will be such that it integrates and augments the business of current model rather than harming it. It would open the horizon of new opportunities for the existing model. Both models should be operated, worked and regulated in a harmonized and synchronized manner. It would be served as a platform to bridge the gaps of existing offline pharmacies and connect the patients with existing offline pharmacies.

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